Clinical Trials for Skin Wrinkling
There are currently 6 ongoing clinical trials investigating treatments for skin wrinkling, including forehead lines, frown lines between the eyebrows, and other facial wrinkles. These studies are testing various forms of botulinum toxin type A and related medications to reduce the appearance of wrinkles and improve patient satisfaction with their appearance. Trials are being conducted in Austria, France, Germany, and the Netherlands.
Clinical trial locations
- Austria
- France
- Germany
- Study on the Safety and Effectiveness of Dantrolene Sodium and Botulinum Toxin Type A for Treating Severe Glabellar Lines in Adults
- Study on the Safety and Effectiveness of IPN10200 and Botulinum Toxin Type A for Adults with Moderate to Severe Upper Facial Lines
- Study on the Spread of LetibotulinumtoxinA Compared to OnabotulinumtoxinA and AbobotulinumtoxinA in Patients with Moderate to Severe Forehead Wrinkles
- Netherlands
Study on the Effectiveness of Clostridium Botulinum Neurotoxin Type A for Reducing Wrinkles in Adults
This trial is being conducted in the Netherlands and focuses on evaluating patient satisfaction with a wrinkle treatment called Bocouture, which contains botulinum toxin type A. The treatment is administered in split doses, meaning smaller amounts are given more frequently than usual.
Main inclusion criteria: Participants must be adults aged 18 to 65 years in generally good health. They should have symmetrical wrinkles on both sides of the face with a moderate severity score, and a satisfaction score between 2 and 8 on a scale from 0 to 10. Participants must be willing to provide informed consent and follow study requirements.
Main exclusion criteria: People with serious skin conditions other than wrinkles, allergies to treatment ingredients, those who are pregnant or breastfeeding, participants in another clinical trial within the last 30 days, and individuals with medical conditions or taking medications that could interfere with the study are not eligible.
Focus and goal: The study aims to measure how satisfied participants are with the treatment results by comparing those who receive Bocouture with those who receive a placebo. The main assessment will occur two months after the last treatment, with monitoring for any adverse reactions throughout the study period.
Investigational drug: Botulinum toxin type A works by blocking nerve signals in muscles, causing temporary relaxation and smoothing of wrinkles. The trial explores whether giving this medication in split doses improves patient satisfaction.
Study on the Safety and Effectiveness of IPN10200 and Botulinum Toxin Type A for Adults with Moderate to Severe Upper Facial Lines
This trial is taking place in France and Germany and is evaluating a new treatment called IPN10200, a type of botulinum toxin, for treating moderate to severe upper facial lines including forehead lines, frown lines between the eyebrows, and lines around the eyes.
Main inclusion criteria: Participants must be between 18 and 65 years old, able to give signed consent, and have moderate to severe upper facial lines. They must be dissatisfied with their facial lines at the start of the study. Female participants of childbearing potential must use effective contraception and have a negative pregnancy test.
Main exclusion criteria: People with known allergies to the study medication, recent facial cosmetic procedures, certain skin conditions affecting the face, pregnant or breastfeeding women, those with medical conditions that could interfere with results, individuals currently taking medications that could affect outcomes, recent participants in other clinical trials, and those with a history of drug or alcohol abuse are excluded.
Focus and goal: The study aims to determine the best dose of IPN10200 that is both safe and effective in reducing the appearance of facial lines. The main assessment occurs on Day 29 after treatment, with participants monitored for several weeks through regular check-ups including physical examinations and assessments of facial lines.
Investigational drug: IPN10200 is a neuromodulator that works by reducing muscle activity to minimize the appearance of wrinkles. The trial includes dose escalation and dose-finding protocols to identify optimal treatment levels.
Study Comparing the Effectiveness and Safety of Botulinum Toxin Type A Products for Treating Frown Lines in Adults
This Netherlands-based study compares five different botulinum toxin type A products for treating glabellar frown lines, which are the vertical wrinkles between the eyebrows. The products being tested are NUCEIVA, Azzalure, VISTABEL, BOCOUTURE, and another similar product.
Main inclusion criteria: Participants must be women aged 18 years or older with moderate to severe glabellar lines who are willing to provide written informed consent. They must have an American Society of Anesthesiologists Physical Status Classification of 1 or 2, meaning they are either healthy or have only mild systemic disease.
Main exclusion criteria: Only females can participate. People outside the specified age range and those considered part of a vulnerable population requiring special protection are excluded.
Focus and goal: The study aims to determine which product is most effective in reducing the appearance of glabellar frown lines and how long the effects last. Participants will be monitored up to week 16 to assess treatment duration. The study also evaluates the impact on quality of life, social functioning, psychological wellbeing including anxiety and depression levels, and effects on headaches and migraines.
Investigational drugs: The trial compares five different formulations of botulinum toxin that work by temporarily relaxing the muscles that cause frown lines, helping to smooth out wrinkles.
Study on the Spread of LetibotulinumtoxinA Compared to OnabotulinumtoxinA and AbobotulinumtoxinA in Patients with Moderate to Severe Forehead Wrinkles
This German trial compares three types of botulinum toxin type A treatments for forehead wrinkles: Letybo, Botox, and Dysport. The study focuses on understanding how these treatments spread under the skin.
Main inclusion criteria: Participants must be between 18 and 75 years old, in stable health, have a Body Mass Index between 16 and 27 kg/m2, and have moderate to severe forehead wrinkling when moving. They must have healthy skin on the forehead with uniform sweating activity. Female participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during the study.
Main exclusion criteria: People with uncontrolled systemic diseases, unhealthy forehead skin, mild forehead wrinkling, or areas on the forehead that do not sweat at all cannot participate.
Focus and goal: The study measures the size of the area where sweating is reduced after injection, which helps researchers understand how each treatment spreads and its effectiveness. The study also evaluates wrinkle thickness and patient satisfaction over six months.
Investigational drugs: The three botulinum toxin preparations being compared all work by relaxing muscles through blocking nerve signals, but the study aims to understand differences in how they spread in the skin.
Study on the Effects of Botulinum Toxin Type A for Treating Moderate to Severe Forehead Lines in Adults
This Austrian study tests different dosages of LetibotulinumtoxinA for treating horizontal forehead lines, which appear when raising the eyebrows.
Main inclusion criteria: Participants must be females aged 18 to 75 years who understand the trial purpose and have given written informed consent. They must have moderate or severe horizontal forehead lines when raising their eyebrows, be able to self-assess their forehead appearance, and have stable medical conditions. Women of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the trial.
Main exclusion criteria: Only women can participate. Those with mild forehead lines or who are part of vulnerable populations requiring special protection are excluded.
Focus and goal: The study assesses the effectiveness and safety of three different dosages of LetibotulinumtoxinA in reducing forehead lines. Participants attend multiple visits over several months where improvement is evaluated by specialists who don’t know which dosage was given. The study also measures participant satisfaction with treatment results.
Investigational drug: LetibotulinumtoxinA is injected into forehead muscles and works by blocking nerve signals to temporarily relax muscles, smoothing out lines and giving skin a more youthful appearance.
Study on the Safety and Effectiveness of Dantrolene Sodium and Botulinum Toxin Type A for Treating Severe Glabellar Lines in Adults
This German trial evaluates a combination treatment called FTP-002/FTP-501 for treating severe glabellar lines, the vertical lines between the eyebrows that appear when frowning.
Main inclusion criteria: Participants must be females who have never received toxin treatments, aged 18 to 65 years, with severe vertical glabellar lines when frowning as assessed by both a doctor and themselves. They must provide written consent and be willing to follow study requirements including attending scheduled visits and avoiding sun or UV exposure. Women of childbearing potential must have a negative pregnancy test.
Main exclusion criteria: Males and those part of vulnerable populations unable to protect their own interests cannot participate.
Focus and goal: The study evaluates the safety and effectiveness of the FTP-002/FTP-501 combination by comparing results with those receiving only FTP-002 or a placebo. Participants receive a single injection and are monitored to assess improvements in glabellar line appearance and how long effects last.
Investigational drugs: FTP-002 and FTP-501 are both given as single intramuscular injections. FTP-002 is tested alone and in combination with FTP-501 to determine if the combination provides better results in reducing severe glabellar lines. Both are neuromodulators that work by affecting nerve signals to muscles.
Summary
The 6 ongoing clinical trials for skin wrinkling represent a focused effort to advance treatment options for facial wrinkles, particularly in the upper face region. Most trials concentrate on botulinum toxin type A formulations, though they explore different aspects including dosing strategies, product comparisons, and combination therapies.
Geographically, Germany hosts the most trials with 3 studies, followed by the Netherlands with 2 trials, while Austria and France each have 1 trial. This concentration in German-speaking countries and Western Europe suggests strong research infrastructure for cosmetic dermatology studies in these regions.
The trials focus on three main facial areas: forehead lines (3 trials), glabellar frown lines between the eyebrows (2 trials), and general facial wrinkles (1 trial). Several studies compare different formulations of botulinum toxin products, including established brands like Botox, Dysport, and Azzalure, alongside newer formulations like IPN10200 and LetibotulinumtoxinA.
Notable aspects include investigations into split-dose administration, product diffusion characteristics, combination therapies with dantrolene sodium, and comprehensive quality-of-life assessments. Most studies require participants to be in generally good health with moderate to severe wrinkles, and several trials are limited to female participants only.
These trials collectively aim to refine existing treatments, identify optimal dosing strategies, and develop new therapeutic approaches for managing facial wrinkles, with emphasis on both efficacy and patient satisfaction outcomes.
